Tyke® is the only ECM specifically cleared for use in neonates and infants.
Tyke was developed based on a request by Pediatric Cardiovascular Surgeons to deliver an ECM material that maintained the biomechanical properties found in our existing products, but was thinner, more pliable and better suited for intracardiac and branch pulmonary artery use in neonates and infants.
Tyke is intended for use in neonates and infants for the repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair. Tyke meets the same biomechanical requirements (tensile strength, suture retention strength and burst strength) as our existing ECM for Cardiac Tissue Repair, and bench testing has shown that Tyke exceeds the specified tensile strength, suture retention strength, and burst strength required for its intended surgical use.
To assess the biological performance of Tyke, patches were implanted in the descending aorta and pulmonary artery of a growing lamb model. Explanted patches were evaluated by an independent, board-certified pathologist. Tyke was found to restore the structural integrity (including the formation of a mature, stable, and fully endothelialized neointima) of the implant site within 90 days (Figure 1). By 180 days, the thickness of the remodeled Tyke patch was similar to the thickness of the adjacent native artery.